MAUDE Adverse Event Report: MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH MED-EL MAESTRO COCHLEAR IMPLANT SYSTEM

Model Number MI1200 SYNCHRONY PIN

Device Problem Migration (4003)

Patient Problems Failure of Implant (1924); Tinnitus (2103)

Event Date 05/10/2021

Event Type  Injury  

Manufacturer Narrative

The device has been explanted and has been returned to med-el hq where it will be evaluated.When available, a device failure analysis will be submitted as a follow-up report.

Event Description

In the last 4 years the user has made no progress with the device despite programming attempts.He has suffered from tinnitus since surgery with and without use of the device.The severity of the tinnitus is on the same level with the use of the device and without.According to the implant registration card a full insertion was not achieved at implantation, reportedly at least 2 channels were extra-cochlear.The user has been re-implanted.There were approximately 3-4 channels extracochlear at explantation.

Event Description

In the last 4 years the user has made no progress with the device despite programming attempts.He has suffered from tinnitus since surgery both with and without use of the device.The severity of the tinnitus is on the same level with the use of the device and without.The user has been re-implanted.There were approximately 3-4 channels extra-cochlea at explantation.

Manufacturer Narrative

Conclusion: device investigations did not reveal any device defect or problem which is expected to have been present whilst implanted.This finding was expected, because according to the recipient report lack of benefit was most likely caused by a post-operative migration of the active electrode out of cochlea.Reportedly 3-4 channels were found extra-cochlea at explantation surgery, 2 of which were extra cochlea since implantation.In addition, the recipient suffered from tinnitus, which was present with and without the audio-processor in use.Mechanical damages found during investigation are attributable to the removal surgery.This is a final report.

• Brand Name: MED-EL MAESTRO COCHLEAR IMPLANT SYSTEM
• Type of Device: COCHLEAR IMPLANT
• Manufacturer (Section D): MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH; innsbruck ; AU
• Manufacturer Contact: laura simonotti ; fuerstenweg 77a; innsbruck 6020 ; AU 6020 ; 57788
• MDR Report Key: 12575728
• MDR Text Key: 274708621
• Report Number: 9710014-2021-00746
• Device Sequence Number: 1
• Product Code: MCM
• UDI-Device Identifier: 09008737094058
• UDI-Public: (01)09008737094058
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P000025
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/13/2020
• Device Model Number: MI1200 SYNCHRONY PIN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/17/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/22/2021
• Initial Date FDA Received: 10/05/2021
• Supplement Dates Manufacturer Received: 09/22/2021
• Supplement Dates FDA Received: 11/17/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/13/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 72 YR
• Patient Sex: Male